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Last Updated: November 22, 2024

NIACIN - Generic Drug Details


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What are the generic sources for niacin and what is the scope of freedom to operate?

Niacin is the generic ingredient in seven branded drugs marketed by Medpointe Pharm Hlc, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Abbvie, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, Wockhardt, Avondale Pharms, Sanofi Aventis Us, and Intl Minerals, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for niacin. Eleven suppliers are listed for this compound.

Drug Prices for NIACIN

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Drug Sales Revenue Trends for NIACIN

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Recent Clinical Trials for NIACIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre de recherche du Centre hospitalier universitaire de SherbrookeN/A
Institut universitaire de cardiologie et de pneumologie de Québec, University LavalN/A
Rhode Island HospitalEarly Phase 1

See all NIACIN clinical trials

Pharmacology for NIACIN
Drug ClassNicotinic Acid
Medical Subject Heading (MeSH) Categories for NIACIN

US Patents and Regulatory Information for NIACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Beijing NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 214428-002 Nov 22, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Purepac Pharm NIACIN niacin TABLET;ORAL 083271-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz NIACIN niacin TABLET;ORAL 083306-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 200484-002 Apr 23, 2014 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203742-002 Feb 22, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising NIACIN niacin TABLET, EXTENDED RELEASE;ORAL 203742-001 Feb 22, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NIACIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN TITRATION STARTER PACK niacin TABLET, EXTENDED RELEASE;ORAL 020381-005 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-001 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-004 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-003 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie NIASPAN niacin TABLET, EXTENDED RELEASE;ORAL 020381-002 Jul 28, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.